The Markingson Case: Investigate the University of Minnesota

I’ve written previously about an egregious and tragic case of research misconduct at the University of Minnesota involving the death of a young man named Dan Markingson. I’m taking up the subject again today to voice support for a petition calling on Minnesota’s governor to investigate the University’s treatment of Mr. Markingson and its conduct in responding to related allegations of wrongdoing. You can (and should) sign the petition here.

Dan Markingson – a vulnerable, psychotic young man – was forced to choose between enrolling in a Pharma-funded drug study or being involuntarily committed (in other words, locked up). A UMN doctor enrolled him in the study despite having just determined that Dan “lack[ed] the capacity to make decisions regarding [his] treatment,” rendering it highly unlikely that Dan could have given valid informed consent to participate. As Dan’s mother, Mary Weiss, observed his mental condition deteriorating, she repeatedly tried to have Dan removed from the trial – at one point asking “Do we have to wait until he kills himself or someone else before anyone does anything?” But the UMN co-investigators in the drug study refused to terminate his participation. Shortly after Ms. Weiss made her desperate plea, Dan Markingson killed himself by cutting his own throat.

Judging by the administration’s public comments, the University of Minnesota appears to believe its conduct in this matter has been entirely beyond reproach. It has steadfastly denied wrongdoing and to my knowledge has never conceded that a single aspect of its conduct was anything less than perfect. This despite the fact that:

In response to the University’s coercive “recruitment” of Markingson, the Minnesota State Legislature passed a law barring people under civil commitment orders from being recruited into psychiatric drug trials. The statute, nicknamed “Dan’s Law,” was a direct rebuke of the University’s conduct.

The Minnesota Board of Social Work found that the study’s coordinator – Jean Kenney, then a UMN employee – “consistently fell below the minimum standards of practice for a clinical social worker.” Specifically, the Board found Kenney had: improperly made medical diagnoses and administered prescription drugs (she was not a doctor), made mistakes about medication dosages, omitted critical information relevant to suicide prevention, kept records “devoid of any clearly articulated, consistent set of treatment goals,” and repeatedly forged a physician’s initials in Markingson’s chart.

Several faculty members, as well as the president of the state chapter of the American Association of University Professors, have criticized the University’s General Counsel, Mark Rotenberg, for appearing to try to intimidate and silence a vocal critic of the University’s treatment of Markingson. (See, e.g., The Chronicle of Higher Education, The Minnesota Post, and the Bioethics Forum.)

Despite all this (and much more), the University has never acknowledged any errors or taken any disciplinary action related to the Markingson case and has repeatedly rejected calls for an independent investigation. That’s probably because from the start the University has handled Dan’s death as a litigation matter. Rather than trying to determine whether there were problems with the way its personnel treated Markingson, the University has focused on minimizing its potential liability. Accordingly, the University appears to run every inquiry related to the case through the office of its General Counsel, Mr. Rotenberg. When Carl Elliott (my mentor as a grad student at UMN) wrote a damning article about the case in Mother Jones, the University’s response came from Rotenberg. When UMN bioethicists called on the University’s Board of Regents to launch an independent investigation, the Regents deferred to Rotenberg. Not surprisingly, he declined.

When you turn to your lawyer, you’re going to get a particular kind of response. The GC isn’t in a position to take an objective look at the circumstances. He’s an advocate. His role is not to make sure the client has conducted itself ethically, but to minimize the client’s risk. Asking your lawyer to respond to allegations of wrongdoing is like asking your PR flacks to do so. Their job is to make their clients look good, not to make sure they’ve acted properly.

Relying on one’s lawyer to address allegations of wrongdoing tends to produce things like Rotenberg’s carefully-worded claim that various entities had “reviewed” the Markingson case and “[n]one found fault with the University.” This is lawyer-talk that creates a false impression while skirting outright lying. For example, among the ostensibly exonerating “reviews” Rotenberg cites is Mary Weiss’s lawsuit against the University. Mr. Rotenberg emphasizes that “[f]ollowing exhaustive factual discovery, all claims against the University . . . were dismissed by the Hennepin County District Court.” This creates the appearance that the court conducted a thorough review of the facts surrounding the Markingson case and determined conclusively that the University had done nothing wrong. Nothing could be further from the truth.

The reality is that the University used legal maneuvers to prevent the court from considering whether it had committed any wrongdoing. Far from convincing the court that the University had acted properly, the University argued it was immune from suit under a Minnesota statute that limits lawsuits against state agencies. In other words, the University convinced the court that it could not be held liable no matter how improperly its employees had behaved. To cite the court’s decision as some kind of vindication of the University is outrageous.

In addition to Mr. Rotenberg’s role as the University’s top defender and advocate, there is another reason he cannot impartially consider requests for an investigation: the General Counsel’s Office is an important player in some of the disturbing events at issue. As noted above, Rotenberg himself has been accused of attempting to intimidate and silence the bioethicist who has most doggedly sought an investigation. The University’s lawyers are also responsible for the disgraceful silencing of Markingson’s mother, Mary Weiss. After avoiding liability by arguing the University was immune from suit, these lawyers then threatened to force Weiss – whose son had died in a University doctor’s “care” – to pay the University’s legal costs of some $57,000. The University used that threat as leverage to get Weiss to forgo an appeal of the trial court’s decision.

Moreover, there are serious questions about documents the University’s lawyers produced – or did not produce – in the Weiss litigation. For example, Weiss’ lawyer says that during the lawsuit the University never produced a HIPAA form signed by Markingson. (Under HIPAA, the hospital could not share Markingson’s private health information with the drug study investigators without his written authorization.) Yet several years after the litigation ended, in response to a complaint filed with the University Rotenberg produced a HIPAA form allegedly signed by Markingson. If this document was not produced in the litigation and was then “discovered” several years later, this raises serious questions about whether the document is legitimate and whether the University’s lawyers met their obligation to produce relevant documents in the Weiss litigation. (See Rule 3.4 of the Minnesota Rules of Professional Conduct.)

The General Counsel’s Office might easily put these questions to rest by either confirming that it produced the signed HIPAA form in the Weiss litigation (and providing Bates numbers so the document can be located) or by explaining why it did not produce the document. So far the University has declined to do so.

In addition, during the litigation the University’s attorneys produced two documents that allegedly showed Markingson was competent to consent to participating in the drug trial (see here and here). Both documents are “evaluation to sign consent forms” that investigators use to show that study participants understand what they’re getting into and what protections they have. The forms produced by the University contain a series of typed questions that the study coordinator (Kenney) was supposed to ask prospective participants, followed by hand-written answers reflecting the participants’ responses. The two documents that allegedly show Markingson’s answers are identical – they appear to be photocopies – except that only one of them bears Markingson’s initials. The reason for the discrepancy is unclear, but it appears Markingson’s initials were added to one of the forms after the original was photocopied. (Notably, as mentioned above, the Minnesota Board of Social Work found that Kenney had repeatedly forged doctors’ initials in Markingson’s medical records.)

More puzzling still, the family of another study participant has come forward with a document that also appears identical to Markingson’s alleged consent form (minus Markingson’s initials). This other participant’s answers are exactly the same as Markingson’s (which by itself is highly suspect), and in fact the document appears to be a photocopy of the same document that allegedly shows Markingson’s responses. Take a look for yourself. In addition, several other families of participants in the drug study have stated they found precisely the same document in their medical files, but to date only one has been willing to produce the document for examination.

These duplicates raise questions about the legitimacy of these documents – particularly in light of Kenney’s numerous, serious deficiencies in her performance as study coordinator, including egregious misconduct related to record-keeping. If these documents were faked or altered, and if the University’s lawyers knew this, producing them in the Weiss litigation would be a very serious breach of the rules of professional conduct.

The General Counsel’s Office claims it has reviewed the “evaluation to sign consent forms” of the 17 study participants at the University of Minnesota and determined that all were legitimate. They have not explained, however, the presence of two copies of Markingson’s consent form (one with initials, one without). Nor have they produced copies of the other participants’ consent forms (whose names could be redacted to protect their privacy) so that these claims of authenticity can be verified.

In short, the University’s General Counsel’s Office cannot objectively assess whether an investigation is necessary – both because its job is to protect the University and because the GC’s Office is an important player in some of the alleged wrongdoing. Since the University continues to refer all requests for an investigation to Mr. Rotenberg, it is clear that some other body must step in.

That’s where the current petition comes in. Minnesota’s governor has made the treatment of mental illness a key priority of his administration. With a large showing of concern and support for an investigation, he might be persuaded to act. I would encourage you to join that effort by signing the petition. You would be in good company.

If you open both documents in Adobe or other pdf viewer, increase size, and put them side by side, you’ll see the crossed out areas over the Subject Initials lines are very different. The form without initials came from the IRB files & is explicable(?) in light of the IRB reminder to Kenney/Olson not to use subjects’ initials. We assume Kenney/Olson copied the evaluation to consent, crossed out DRM’s initials & sent it to the IRB. However Kenney/Olson did not copy the evaluation to consent with initials & PSY prefix. So there is a third evaluation to consent floating around.

The evaluation with initials makes me wonder where it came from. If it came from the study records in the Ambulatory Research Center, the study monitor and FDA inspector absolutely would have noticed the two cross outs above the Subject Initials line. From day one research personnel are taught how to make corrections: line through incorrect information, add correct information, initial & date it & add a note to file explaining the correction. According to the FDA inspection report the study monitor did quarterly audits. Dan took his life in May 2004; the FDA inspection began on 3 Jan 2005, and so the monitor would have audited records once if not twice during this period. The “incorrect corrections” are baffling and scary.

Also, the General Counsel’s Office should have reviewed 20 evaluations to consent. 17 subjects were randomized in CAFE, but since there wasn’t a separate screening consent, there should be evaluations to consent & consent forms for the 3 subjects who didn’t enter the randomization phase. See p. 16 of the FDA EIR.

Why should we believe their determination of legitimacy given UM’s track record of troubling behavior in the cases of Drs. Barry Garfinkel and James Halikas?

thomas hussman

May 9, 2014 at 2:00 pm

I have always dreamed of a day when I could actually graduate from our great university here in Minnesota. In my youth I had some educational stops and starts. At age 17 I determined to go to medical school, with the goal to become an emergency surgeon. I failed at this effort.

At age 39 I walked into the office of admissions intending to get admitted. I recall vividly that day, I was well groomed and clean. I was polite and positive. The medical school plan was gone. I now planned to just get a classical education, english, history, etc.. I was not looking for financial, I intended to pay my own way.

The office was quiet, with some people present. I met a young woman employee at the front area and we began to talk. The moment she realized I was there representing myself, that the proposed educational plan was for me, she said, “how old are you?” I was stunned and silent. She was making gestures with her arms now, as she rather loudly, and with an unfriendly tone, advised to go to the extension division, and “maybe they can help you.”

Today I will return to the school and together with some of my friends from the medical school, human rights department, and bioethics, we will stand outside a meeting and protest the indifference by lawyers and others concerning a clinical trial problem that occurred ten years ago.

As I prepare to make the journey, I can’t help wondering about the unknown possibilities in mental illnesses. As we strive to reach our goals, is it possible that the mind has a breaking point, where a discouraging word finally causes the chemicals to stop working. Add some concoctions to the chemical strain and who knows what will happen?